Tangling Over $5.5 Billion Stem Cell Measure: CIRM Board Member vs. its Former Chairman

Robert Klein is on the left, Jeff Sheehy on right at CIRM
directors meeting. Art Torres, vice chair of the board is in
the middle. CSCR photo

The two men once worked together over the last 16 years to spend $3 billion in state funds on stem cell research in California. This week, however, they were very publicly on opposite sides of a ballot initiative to spend $5.5 billion more. 

The initiative is Proposition 14, which would require the state to borrow the additional billions. The measure would also substantially expand the scope of the state stem cell agency, known formally as the California Institute for Regenerative Medicine (CIRM).  

Both men, Robert Klein and Jeff Sheehy, served on the CIRM board, regularly approving hundreds of millions of dollars in research awards annually. Klein is a Palo Alto real estate developer and was the first chairman of the agency. He directed the writing of Proposition 14 and now heads the campaign.  He left his post as chairman in 2011.

Sheehy continues to serve on the CIRM board and has since 2004. He is a patient advocate member of the board, its former Science Subcommittee chair and a nationally recognized HIV/AIDs advocate. Sheehy was the lone dissenting vote when the CIRM board endorsed Proposition 14 in June, although he says the agency has done "tremendous" work.

They came together "remotely" when they participated Oct. 5 in a public radio show, KQED's Forum with Michael Krasny, that is heard throughout California on public radio stations. 

Klein and Sheehy bristled at times during the 38-minute broadcast. Klein said figures presented by Sheehy were "completely false." Sheehy said Klein's financing mechanism in Proposition 14 was "very dodgy" and "ridiculous." 

In the initial years of financing, Sheehy said, "It's like getting a credit card and then getting another credit card to carry the interest (from the first credit card)."

Longstanding issues were also raised concerning conflicts of interest on the CIRM board and other deficiencies identified in an evaluation of CIRM by the prestigious Institute of Medicine (IOM). The 2012 study was commissioned by CIRM itself at a cost of $700,000. Both Klein and Sheehy supported funding the study as a way to secure what they thought would be a gold standard endorsement of the agency. 

Klein's initiative does little to deal with the issues raised by the study, which said "inherent conflicts of interest" exist on the board. The report also recommended that the 29-member board be overhauled completely and not expanded.  Proposition 14 would increase the board size to 35, however, increasing conflicts of interest. The measure also does not address the management and governance problems cited by the study.

An analysis last month by the California Stem Cell Report showed that 79 percent of the awards approved by the CIRM board went to institutions that had links to board members even though the "institutional" members are not permitted to vote on awards to their institutions. Conflicts of interest have been so pervasive at times that only six or seven members were allowed to vote on awards. 

Sheehy and Klein also talked briefly about state spending priorities in the Covid year and the state's ongoing affordable housing, education and homeless problems. Overall, the KQED program provided only a tiny peek at the issues involved in Proposition 14. 

Klein's position can be fully explored on his campaign's web site. Over the last 12 months, Sheehy has aired his position at CIRM board meetings and in submissions to the California Stem Cell Report. Here is what Sheehy wrote regarding his no vote on endorsement of the ballot measure.

A detailed look at the findings of the IOM report and the current status of CIRM's response is contained in the new book "California's Great Stem Cell Experiment: An Inside Look at a $3 Billion Search for Cures."  The book was written by the publisher of this blog and grew out of more than 15 years of close observation of the stem cell agency. 

Head-to-Head on Proposition 14: 'Fatally Flawed,' Life-Saver or Both?

2012 CIRM video of Sandra Dillon (on right) and Catriona Jamieson of UC San Diego

Sandra Dillon says she owes her life to the California stem cell agency, and she wants California voters to give it $5.5 billion more to help save the lives of many more, including someone they love. 

Dillon made her comments in a piece carried last month in the San Diego Union-Tribune. Her article was paired with another commentary in the paper that strongly opposed Proposition 14 on this fall's ballot. It was written by Jeff Sheehy, a patient advocate member of the board of the California Institute for Regenerative Medicine (CIRM), the official name of the stem cell agency.  

Together, Dillon's and Sheehy's commentaries capture the essence of the arguments for and against the ballot initiative and highlight what is at stake this fall. And that is the continued existence of the stem cell agency, which was created in 2004 by another ballot initiative that provided it with $3 billion in money borrowed by the state. That funding is all but gone. If voters reject Proposition 14, CIRM will begin closing its doors this winter. 

(The actual cost to taxpayers, it should be noted, is about $4 billion in the case of the 2004 measure and an estimated $7.8 billion for Proposition 14.)

When Dillon was 28, she was diagnosed with a rare form of blood cancer called myelofibrosis. She wrote in the San Diego paper, 

"Upon learning of my cancer diagnosis, I was left feeling helpless, afraid and searching for answers about how this disease would affect my everyday life, what I could do to fight it, and how much time I had left to live....

"It is because of California’s forward-looking leadership in passing Proposition 71 in 2004 — hoping to find treatments and cures for chronic diseases and illnesses — that has allowed me to still be here today." 

Dillon concluded,

"The passage of Proposition 71 helped save my life. It is unimaginable to think that Californians would vote to discontinue this amazing effort — I don’t know where I would be or what condition I would be in if it wasn’t for the investment Californians made nearly two decades ago."

Dillon's experimental therapy involved research by Catriona Jamieson of UC San Diego, who has received $17.3 million from the stem cell agency.

In the other commentary, Sheehy, who has served on the CIRM board since 2004 and was chairman of its science subcommittee, was deeply critical. He was the only member of the CIRM to votes against endorsing the measure. 

The California Stem Cell Report carried a piece last month summarizing what Sheehy had to say in his piece, which was headlined,  "Why Prop. 14 is unaffordable, unnecessary, fatally flawed and unsupportable."

But to refresh readers, Sheehy, whose article was solicited by the newspaper, said, 

"It must seem odd that someone who has spent countless hours over the last 15 years as a member of the governing board of the California Institute for Regenerative Medicine (CIRM) would oppose Proposition 14, which seeks to provide $5.5 billion in new funding for the stem-cell agency. While I value CIRM and its work to date, Proposition 14 commits California to spending money it does not have — $7.8 billion including interest for research that is already well-funded. Plus, CIRM’s pre-existing flaws are actually exacerbated by new provisions in the measure."

"And after spending all of that money, not a single U.S. Federal and Drug Administration-approved product has materialized on which CIRM’s funding played an important role."

"Proposition 14 will add at least another $260 million a year in annual repayments. That means California taxpayers will be on the hook for $587 million a year for stem-cell research. Remember state imperatives such as education, health care and housing are not only chronically under-resourced but with a looming deficit, will be starved for funding because bonds must be repaid first. Cuts have already happened and more are likely on the way. Critical needs will go unfunded."

California's Alpha Stem Cell Clinic Network: Online Symposium Set for Thursday

Science Direct graphic

Californians -- not to mention the entire world -- will have a chance Thursday to get a close-up look at one of the signature efforts of the state's $3 billion stem cell agency -- the Alpha Clinic Network, which stretches from San Diego to Sacramento. 

The online occasion is the annual symposium for the network, which was started with $50 million from the stem cell agency, known formally as the California Institute for Regenerative Medicine (CIRM). 

The meetings have not always been available online.  This year, Covid-19 forced the session into cyberspace, making it available to vastly larger numbers of persons. 

CIRM's blog, The Stem Cellar, yesterday highlighted a couple of topics. Kevin McCormack, CIRM's senior director of communications, wrote, 

"One of the topics being featured is research into Covid-19. To date CIRM has funded 17 different projects, including three clinical trials. We’ll talk about how these are trying to find ways to help people infected with the virus, seeing if stem cells can help restore function to organs and tissues damaged by the virus, and if we can use stem cells to help develop safe and effective vaccines.

"Immediately after that we are going to use Covid-19 as a way of exploring how the people most at risk of being infected and suffering serious consequences, are also the ones most likely to be left out of the research and have most trouble accessing treatments and vaccines."

The agenda also includes a look at rare diseases and unmet medical needs. You can register for the event here. It begins at 9 a.m. PDT (4 p.m. Greenwich Mean Time).

"California's Great Stem Cell Experiment: Inside a $3 Billion Search for Cures:" A New Book on the State's Stem Cell Agency

David Jensen

A new book devoted to the life and times of California's nearly 16-year-old stem cell research program is now available on Amazon. The book chronicles the stem cell agency's story from its early days to its current imperiled existence. 

The book is called "California's Great Stem Cell Experiment: Inside a $3 Billion Search for Cures." It was written by yours truly, David Jensen, who has covered the agency since January 2005 and who has published some 5,000 items about the program on this blog, the California Stem Cell Report.

The book explores the agency's performance as 20 million Californians vote this month and next to decide whether to provide $5.5 billion more for the California Institute for Regenerative Medicine (CIRM), as the agency is officially known. Questions addressed include: 

• Has CIRM fulfilled the expectations raised by the 2004 campaign?
• Has its work since then been worth $4 billion (CIRM's cost including interest on the state bonds that finance its work)?
• What are the important elements and new directions created by Proposition 14 in addition to the $5.5 billion ($7.8 billion with interest), and does the measure fit with the state's current priorities? 

CIRM is unique in California's history, which has never seen an enterprise like this. It is also unique nationally. No other state has launched a scientific stem cell program of this magnitude.  And it is an agency that operates outside of the bounds of what many consider normal state government controls and finance. 

At the same time, even its opponent will acknowledge the significance of CIRM's work, which includes helping to finance 64 clinical trials and the creation of what it calls an Alpha Clinic Network throughout the state. 

In 2012, CIRM heard from the Institute of Medicine, which CIRM hired to conduct a $700,000 examination of the agency's work. The book re-examines the IOM findings, which were both laudatory and critical, and reviews CIRM's response.  

Along with critics, the book brings to readers the voices of CIRM supporters, its executives and former officials, including the first president of the agency, Zach Hall; its first chairman and leader of the 2020 campaign, Robert Klein; its current president, Maria Millan; its current chairman, Jonathan Thomas, and former president, Randy Mills, who introduced CIRM 2.0 and who is now president of the Sanford Burnham Prebys Medical Discovery Institute in La Jolla, Ca.

One also cannot forget the CIRM governing board director who early on who looked at the 2004 Proposition 71 governance structure for the agency and called it a "dog's breakfast." 

You can purchase "California's Great Stem Cell Experiment" by clicking on this sentence, which will take you to Amazon.  

Proposition 14: Pros and Cons of Stem Cell Research in California 2020

Editor's note: The author of this piece is Ben Kaplan of Palo Alto, who appeared in a TV ad for the 2004 ballot measure that created the California stem cell agency. I talked with him recently by phone and invited him to submit his thoughts on the latest stem cell ballot measure, Proposition 14. Here is his article. 

 

By Ben Kaplan

Ben Kaplan

My story begins when my twin brother Ollie and I were born ten weeks prematurely. Despite his early birth and low birth weight, Ollie never had any lasting health problems, but I did. Just five days after my birth, I had a brain hemorrhage, or stroke, which caused cerebral palsy, specifically “left hemiplegia,” or weakness and paralysis on the left side of my body. I have been a supporter of stem cell research and regenerative medicine for over 20 years, with the hope it may lead to new treatment for my condition. During this time, I have seen research make great strides, from initially being conducted mostly in laboratory studies, to its application in human clinical trials.

California has been a trailblazer in state ballot initiatives for over 40 years. These have set national trends for issues and are often copied or emulated by other states: Prop 13 (property taxation), Prop 187 (Immigration), 209 (Affirmative Action) 215 (medical cannabis), 227 (bilingual education), etc. Proposition 71 in 2004 did this for stem cell research by establishing the California Institute for Regenerative Medicine (CIRM). Since then, several other states have passed their own ballot initiatives or legislation to fund stem cell research. This has created new momentum for increased federal funding.

Another benefit of CIRM funding is the development of private and philanthropic partnerships. The demonstration of a commitment by California to fund and support research and laboratory construction has led private foundations and other donors to contribute funds, dramatically accelerating the pace of stem cell research. The investment in research following the passage of Prop 71 also attracted researchers, scientists and private companies to California, providing financial incentives to open offices and laboratories in the state. In addition, CIRM created a research infrastructure for California by developing a system to award grants and share research data and results, giving it a major advantage over other states, and some countries. These partnerships are important because embryonic stem cell research cannot always be conducted in facilities built using federal funds due to pro-life and taxpayer groups, who have raised ethical and fiscal concerns about using public funding for research on embryonic tissue. CIRM research centers are a way around this roadblock by increasing scientific freedom, promoting research collaboration and hastening the development of new therapies and treatments.

In addition, CIRM has created economic expansion, providing a major boost to the burgeoning field of regenerative medicine. Progress in research funded by CIRM has led to a growing body of scientific evidence that treatments from stem cells may be available to people with debilitating and life-threatening conditions in the near future.

Stem cell research funding is on the ballot in California in 2020 as Proposition 14. This proposition has both potential benefits and drawbacks. One argument in favor is that it will continue and enhance California’s leadership position in support of stem cell research. It can also boost the state’s economy. Treatments may lower healthcare costs and improve health, which may lead to increased employment, worker productivity and economic growth. While the long-term outcome of stem cell research remains uncertain, new discoveries are producing evidence that is leading to clinical trials, allowing treatments to move closer to realization.

However, the COVID19 outbreak has also made Proposition 14’s fate uncertain. While stem cell research may lead to new treatments, it has placed unanticipated stress on California’s budget. However, new research is demonstrating the potential application of stem cells as a possible treatment for the virus. Given this pandemic, how will Proposition 14 fare? While the ultimate outcome is yet to be determined, it may depend on a delicate balance between potential treatment outcomes in the future versus expenses for the COVID19 pandemic in the present.

Recently, physicians at Stanford University, in a clinical trial partially funded by CIRM, have found that neural stem cells injected in rats with a condition similar to CP will travel to the damaged part of the brain and repair it. A clinical trial is also currently in progress at the Mayo Clinic using neural stem cells derived from bone marrow to treat hemorrhagic stroke. Private companies are pursuing similar research, with an eye to developing new therapies and treatments.

As stem cell science progresses and it becomes possible to implant stem cells into the brain, it is possible that I could have improved mobility in my left hand and foot, balance and coordination. This would enable me to do so many things that are now challenging, if not impossible, and would greatly improve and enhance my quality of life and that of many others.